Job summary
An exciting opportunity has arisen for a detail orientated, analytical, self-motivated, and committed individual to join our Quality Assurance team as Validation Analyst within the Welsh Blood Service (WBS).
Working for the WBS can be an incredibly rewarding experience for several reasons, both personally and professionally, providing a supportive environment, a sense of purpose and allowing you to make a difference in people's lives.
The position of Validation Analyst is offered on a permanent basis to collaboratively support Computer Systems Validation to ensure that our systems, processes, and products meet the highest standards of regulatory compliance and performance.
The ideal candidate must have analytical experience, excellent communication skills, experience of working to strict deadlines and the ability to work proactively, independently, actively contributing within a team environment.
For an informal conversation about the role please contact Laurie Thomas, Head of Validation & Risk Management - Laurie.Thomas@wales.nhs.uk
Main duties of the job
The Validation Analyst will be responsible for contributing towards the achievement of Medicines and Healthcare products Regulatory Agency (MHRA) compliance for Validated Systems throughout the WBS (a GxP critical environment) through:
The implementation of, and adherence to, the WBS Validation Policies, Strategies and Standard Operating Procedures (SOPs).
Assisting in the production of Validation deliverables, including User Requirements Specifications, Validation Plans, Qualification Protocols, Test Scripts and Reports.
Participating in Qualification execution.
Ensuring all Validation deliverables are completed to Good Automated Manufacturing Practice (GAMP) guidelines and in accordance with Good Documentation Practice (GDP) and ALCOA+ principles.
Providing advice and support to project teams with regard to promoting validation best practice aligned to organisational requirements.
The ability to speak Welsh is desirable for this post; English and/or Welsh speakers are equally welcome to apply.
About us
Here at Velindre University NHS Trust we are extremely proud of the specialist services we provide across the whole of Wales in our cutting-edge Velindre Cancer Centre and our award-winning Welsh Blood Service, as well as the expertise of our corporate functions that bring the two divisions together. We are also fortunate to host the NHS Wales Shared Services Partnership and Health Technology Wales and have developed strong partnership working with these expert services.
Formed in 1994, the Trust has a dedicated workforce that continuously strives to apply the key principles of value based healthcare through a wide array of roles. We play a vital role in the communities we support and have ambitious plans for the future to continue to improve the services we deliver. We strive to maintain our core values in everything we do by being; accountable, bold, caring and dynamic, and ensuring the best possible care for our patients and donors.
If you want to work for an organisation that prides itself on making a real difference and offers exciting career opportunities then Velindre University NHS Trust is the place for you.
Visit our website to find out more https://velindre.nhs.wales/
Job description
Job responsibilities
You will be able to find a full Job description and Person Specification attached within the supporting documents or please click Apply now to view in Trac.
Job description
Job responsibilities
You will be able to find a full Job description and Person Specification attached within the supporting documents or please click Apply now to view in Trac.
Person Specification
Qualifications
Essential
- BSc (Hons) Relevant Degree or equivalent experience of process and software validation
Knowledge
Desirable
- Knowledge of a Blood Establishment function
- Knowledge of QMS including change control, CAPA & Incident Reporting
- Project Management
Experience
Essential
- Experience of working within a Quality Management System
- Experence of working with GMP & GAMP methodologies
Desirable
- I.T. experience in an analytical role and / or significant experience within WBS at an appropriate level
- Software development, Analysis & Programming
Skills & Attributes
Essential
- Excellent analytical skills
- Computer literate with Microsoft Office
- Ability to communicate effectively both orally and in written format
- Ability to work independantly and proactively
- Ability to organise own workload
- Ability to work as part of a team
- Ability to interact effectively with people at all levels
- Ability to work under pressure and to strict deadlines
- Ability to work to work on own initiative
Other
Desirable
- Ability to be flexible in hours worked in accordance with exigencies of the service
- Must be able to travel as required
- Welsh speaker (level 1) or willingness to work towards
Person Specification
Qualifications
Essential
- BSc (Hons) Relevant Degree or equivalent experience of process and software validation
Knowledge
Desirable
- Knowledge of a Blood Establishment function
- Knowledge of QMS including change control, CAPA & Incident Reporting
- Project Management
Experience
Essential
- Experience of working within a Quality Management System
- Experence of working with GMP & GAMP methodologies
Desirable
- I.T. experience in an analytical role and / or significant experience within WBS at an appropriate level
- Software development, Analysis & Programming
Skills & Attributes
Essential
- Excellent analytical skills
- Computer literate with Microsoft Office
- Ability to communicate effectively both orally and in written format
- Ability to work independantly and proactively
- Ability to organise own workload
- Ability to work as part of a team
- Ability to interact effectively with people at all levels
- Ability to work under pressure and to strict deadlines
- Ability to work to work on own initiative
Other
Desirable
- Ability to be flexible in hours worked in accordance with exigencies of the service
- Must be able to travel as required
- Welsh speaker (level 1) or willingness to work towards
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
